MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COCR INTEGRAL CENTRALIZER 11MM; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Device Slipped (1584); Metal Shedding Debris (1804); Malposition of Device (2616)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Swelling (2091); Toxicity (2333); Deformity/ Disfigurement (2360); Test Result (2695); No Code Available (3191)

Event Date 12/01/2014

Event Type  Injury  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, ¿material sensitivity reactions.¿ number 4 states," loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, or excessive activity." number 6 states, "inadequate range of motion due to improper selection or positioning of components." number 10 states, "fretting and crevice corrosion can occur at interfaces between components." number 13 states, "problems of the knee or ankle of the affected limb or contralateral limb aggravated by leg length discrepancy, too much femoral medialization or muscle deficiencies." number 14 states, "postoperative bone fracture and pain." this report is based on allegations set forth in plaintiff¿s complaint and the allegations contained therein are unverified.This report is number 5 of 5 mdrs filed for the same event (reference 1825034-2015-05166 / 05167 / 05169 / 05170 / 05171).

Event Description

It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2008.During the procedure, the patient's calcar fractured upon insertion of the stem, which required the removal of the inserted stem.A cerclage wire was utilized to close the fracture and a new femoral stem was implanted successfully.Subsequently, patient underwent a revision procedure on (b)(6) 2014 due to allegations of pain, swelling, leg length discrepancy, malpositioned acetabular component, loose femoral component, and elevated metal ion levels in conjunction with a soft tissue mass.During the revision, it was discovered that the acetabular cup was retroverted and well fixed.Possible fretting at the trunnion/head junction, stem subsidence, pseudotumor, soft tissue mass and fractured cement were also noted.All components were removed and replaced to complete the procedure.This report is based on allegations set forth in plaintiff's complaint and the allegations contained therein are unverified.

• Brand Name: COCR INTEGRAL CENTRALIZER 11MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: megan haas ; 56 e. bell drive; warsaw, IN 46582 ; 5743726700
• MDR Report Key: 5331808
• MDR Text Key: 34569948
• Report Number: 0001825034-2015-05171
• Device Sequence Number: 1
• Product Code: JDG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK942479
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 12-162611
• Device Lot Number: 933040
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR